Over-the-counter drug · ANDA

Ibuprofen IB (Ibuprofen) NDC 67091-369

Ibuprofen 200 mg/1 · Tablet, Coated · Oral · WINCO FOODS, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67091-369Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67091-0369Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
67091-369-10670910369101 BOTTLE, PLASTIC in 1 CARTON (67091-369-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 1, 2020
67091-369-50670910369501 BOTTLE, PLASTIC in 1 CARTON (67091-369-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 1, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Ibuprofen IB
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
WINCO FOODS, LLCNDC labeler code 67091
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202312
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 67091-369_af886d56-0d28-ec1b-e053-2a95a90ae531SPL ID af886d56-0d28-ec1b-e053-2a95a90ae531SPL set ID ee867519-227f-44ba-ba8b-2dbefcc9fc67RxCUI 310965UNII WK2XYI10QMUPC 0070552230286

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N467091036910 followed by a unit qualifier and the quantity

Package 67091-0369-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67091-369

What is NDC 67091-369?
67091-369 is the product NDC for Ibuprofen IB (ibuprofen), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by WINCO FOODS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen IB (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
WINCO FOODS, LLC, NDC labeler code 67091. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen IB?
1 other product NDC are listed under this name. See all Ibuprofen IB NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ibuprofen IB NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen IBibuprofenIbuprofen 200 mg/1Tablet, CoatedOralWINCO FOODS, LLC67091-36867091-0368-50

Other NDCs under ANDA 202312

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202312
ProductStrengthForm · routeLabelerProduct NDC
Assured IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralSpirit Pharmaceuticals LLC68210-4139
IbuprofenIbuprofen 200 mg/1TabletOralWalgreens0363-9593
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralBETTER LIVING BRANDS LLC.21130-358
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralBETTER LIVING BRANDS LLC.21130-359
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralTOPCO ASSOCIATES LLC36800-286
IbuprofenIbuprofen 200 mg/1TabletOralTOPCO ASSOCIATES LLC36800-662
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-116
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-312
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralHYVEE INC42507-112
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralHYVEE INC42507-865
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralDemoulas Super Markets, Inc53942-112
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-111
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-112
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-811
IbuprofenIbuprofen 200 mg/1TabletOralGranules India Limited62207-320
IbuprofenIbuprofen 200 mg/1TabletOralGranules India Limited62207-321
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION INC63868-570
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION INC63868-571
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-111
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-301

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